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STERI-WATER®

STERI-WATER® is a sterile, Purified Water, USP grade that is processed to comply with the standards required by the pharmaceutical, biotechnology, medical device, and healthcare industries. STERI-WATER® is produced through an RO filtration process and system that is validated, routinely monitored, and passes all USP monograph requirements for “Purified Water, USP”. The product is manufactured in a Grade A, aseptic filling operation, filtered at 0.2 microns, quadruple bagged and gamma irradiated at a validated 10-6 SAL dose to render the product sterile.

STERI-WATER® is produced through an RO filtration process and system that is validated, routinely monitored, and passes all USP monograph requirements for “Purified Water, USP”

2 de 2 Productos

STERI-WATER - Non-Sterile

STERI-WATER - Sterile

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  • Filtrado a 0.2 micrones
  • Filter Bubble Point tested and sterilized
  • Quadruple Bagged. Each 16 ounce (473 mL), one gallon (3.78L) and 2 gallon (7.56 L) sterile container are double bagged in easy tear packaging and the contents of the case double bagged. The 55 gallon (200 L) container is double bag packaged and skidded.
  • Quadruple bagged in the ABCD Cleanroom Introduction System® provides for each sterile container to have one layer (bag) removed in each classification, Grade (A-D), resulting in no spray down.
  • Gamma Irradiated by a validated dose at a 10-6 SAL
  • Delivered with lot specific analytical, irradiation, and sterility (USP <71> data tested to current USP compendium
  • Completely lot traceable from start to finish
  • Completely validated for sterility and 10 year shelf life
  • Fabricado de acuerdo con las cGMP.
  • Fabricado dentro de un sistema cerrado donde los niveles de endotoxinas están controlados
  • STERI-WATER® 55 gallon (200L) container is packaged and delived with all required dispnsing hoses atop the container and inside the first sterile bag for easy dispensing.
  • Los componentes se lavan con aire filtrado de 0.2 micrones antes del ensamblaje
  • Llenado en una sala limpia ISO 7 (Grado B)
  • Filled into 16 ounce (473 mL), one gallon (3.78L) and 2 gallon (7.56 L) containers and 55 gallon (200L) drums.
  • STERI-WATER® is an innovative solution for GMP facilities that demand the use of a Purified Water, USP in their daily operations but do not have it readily available on site.
  • STERI-WATER® is ready-to-use and can be used throughout any facility for chemical formulation, disinfectant dilution, cleaning, rinsing, and lubrication. Lubrication of moving parts, process lines, and conveyors is essential for continuous and effortless manufacturing.
  • STERI-WATER® can bridge the gap during shutdown period where maintenance on in-house RO systems may be required.
  • Quadruple bagging (ABCD Cleanroom Introduction System®) assure elimination of outer bag spray down as one layer is removed in each classification.
  • Delivered with lot specific analytical, irradiation, and sterility (USP <71> data tested to current USP compendium
  • Etiquetado individualmente con número de lote y caducidad

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